Senior GXP System and Process Specialist (Pharmaceutical, Remote)

Job summary

Seeking a specialist with extensive experience in Veeva RIM and regulatory GxP systems to enhance business system operations and ensure effective use of Veeva RIM systems in regulatory document and submission management.

Qualifications

• Master’s degree in Life Sciences or Information Technology/Science
• Several years of experience in Regulatory Affairs or Regulatory Operations
• Understanding of regulatory end-to-end processes
• Familiarity with global regulatory requirements (e.g., eCTD, IDMP)
• Experience in cross-functional and global environments

Responsibilities

• Serve as business lead and subject matter expert for Veeva RIM applications
• Ensure system supports end-to-end regulatory processes and requirements
• Optimize system usage in alignment with business and regulatory needs
• Evaluate, plan, and implement system change requests
• Lead impact assessments and implement Veeva RIM releases
• Coordinate testing, validation, and deployment of new functionalities
• Engage with stakeholders across the Veeva RIM user community, IT, Quality, and external partners
• Ensure system inspection readiness in collaboration with the team

Skills

• Strong analytical and problem-solving skills
• Ability to translate business needs into digital solutions
• Structured and proactive approach to change and project management
• Excellent stakeholder management and communication skills

Education

• Master’s degree in relevant field

Tools

• Veeva Vault RIM and other Veeva systems